The Use of Laser in the Treatment of Atrophic Vulvovaginitis

Lasers Clinical Trial

Official title:

The Use of Laser in the Treatment of Atrophic Vulvovaginitis and Its Consequent Improvement in Sexual Satisfaction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04297319
• Other study ID #: 5076
• Status: Terminated
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2022
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.

Description:

Thermal laser treatments are proposed as the newest treatments for atrophy. Through the thermal effect it would stimulates de mucosa, enhances the collagen component and the vascularization. Collagen remodeling and new collagen synthesis has been suggested as a mechanism of laser induced skin resurfacing and remodeling of vaginal connective tissue.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Menopause women with vulvovaginal symptoms of atrophy

• No previous estrogen treatment for the last 30 days

• Active sexual life (vaginal penetration)

• Accept to participate

• Pap atrophy or hypotrophy in the last year

Exclusion Criteria:

• Vulvovaginal diseases

• Abnormal uterine bleeding

• Antidepressants drugs

• Uncontrolled diabetes

• Cervical intraepithelial lesions or cancer

• Photosensitized or under treatment with photosensibilized drugs

• Collagen diseases

• Vulvovaginal infections in the last 15 days

• Immunosuppressed patients or under immunosuppressed treatments

Related Conditions & MeSH terms

• Atrophy
• Atrophy of Vagina
• Atrophy Vulva
• Lasers
• Vulvovaginitis

Intervention

Procedure:
• Laser diiodo
3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.
• Laser Placebo
3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

Adabi K, Golshahi F, Niroomansh S, Razzaghi Z, Ghaemi M. Effect of the Fractional CO(2) Laser on the Quality of Life, General Health, and Genitourinary Symptoms in Postmenopausal Women With Vaginal Atrophy: A Prospective Cohort. J Lasers Med Sci. 2020 Win — View Citation

Knight C, Logan V, Fenlon D. A systematic review of laser therapy for vulvovaginal atrophy/genitourinary syndrome of menopause in breast cancer survivors. Ecancermedicalscience. 2019 Dec 12;13:988. doi: 10.3332/ecancer.2019.988. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participant with Adverse events reported in each visit	It will be evaluate the number of patients that reported adverse events such as dyspareunia, irritation, edema, vaginal dryness, genital bleeding, vaginal discharge, pain, lesions	Baseline,and week 48
Primary	Change from Baseline in Female Sexual Function Index questionnaire	Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome	baseline, and week 4 after treatment
Primary	Change from Baseline in Female Sexual Function Index questionnaire	Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome	baseline,and week 12 after treatment
Primary	Change from Baseline in Female Sexual Function Index questionnaire	Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome	baseline, and week 36 after treatment
Primary	Vaginal Cytology Improvement	Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy	baseline, and week 4 after treatment
Primary	Vaginal Cytology Improvement	Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy	baseline, and week 12 after treatment
Primary	Vaginal Cytology Improvement	Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy	baseline, and week 36 after treatment
Primary	Change in vaginal acidity measure	the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)	baseline, and week 4 after treatment
Primary	Change in vaginal acidity measure	the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)	baseline, and week 12 after treatment
Primary	Change in vaginal pH measure	the normal vaginal ph is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)	baseline,and week 36 after treatment
Secondary	Number of patient with Local Estrogen therapy requirement post intervention	Number of patients that Need estrogen replacement for atrophy vulvovaginal symptoms, despite the intervention.This will be evaluate with a Yes/No question.	baseline,and week 48